DePuy Hip Implants Are Resulting In Severe Problems
It's been a long time since I last posted. Between then and now, I had several significant cases set for trial that required almost all my time. One of these cases ended in a week-long trial before getting a good result for my client who suffered catastrophic injuries. After any long trial, one of the greatest challenges is simply catching up on the things you missed. So, I hope to return to regular posting here.
In August, DePuy Orthopedics, Inc. (a Johnson & Johnson company), issued a recall notice for its ASR hip replacement products. These products are the ASR XL Acetabular System and the ASR Hip Resurfacing System. According to The Wall Street Journal, the company sold approximately 93,000 of these devices before phasing out their production last year. The ASR Hip Resurfacing System was only available outside the United States. However, the ASR XL Acetabular System was implanted in patients throughout the United States.
The Food & Drug Administration (FDA) approved the ASR XL Acetabular System for implantation in the U.S. in 2005. Unfortunately, the FDA apparently approved the device without requiring clinical trials. Now, we learn that the device has a much higher failure rate than other similar products. This is a fact that DePuy admits in its recall notice. The device can generate metallic debris as it wears. Patients can suffer pain, difficulty walking, fractures, infection, and damage to surrounding tissue. Because of these problems, additional surgery can be required.
Again, we see the results of a system that rushes products to the market without adequate information or testing. It is unfortunate that the unsuspecting patients who underwent these implants may suffer problems and require additional surgeries that could have been avoided through earlier clinical trials. The companies who manufacture these products and our regulatory system, should be focused on bringing the safest products possible to the physicians and patients using them.
